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COVID19 convalescent plasma infusion
COVID19 convalescent plasma infusion is a Passive immunotherapy / Convalescent plasma Biologic drug developed by Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno. It is currently in Phase 3 development for COVID-19 (severe or life-threatening disease), COVID-19 (hospitalized patients).
COVID-19 convalescent plasma infusion transfers antibodies and immune factors from recovered patients to provide passive immunotherapy against SARS-CoV-2.
Convalescent plasma infusion has been studied as a potential treatment for COVID-19, with various clinical trials, such as NCT04415086, investigating its safety and efficacy in patients with COVID-19. The mechanism of convalescent plasma infusion is currently unknown, but it involves the transfer of antibodies from recovered individuals to those with active infections.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | COVID19 convalescent plasma infusion |
|---|---|
| Sponsor | Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno |
| Drug class | Passive immunotherapy / Convalescent plasma |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
The infusion contains polyclonal antibodies and other immune components from donors who have recovered from COVID-19, which neutralize the virus and enhance immune clearance in infected recipients. This passive immunotherapy approach aims to reduce viral load, prevent disease progression, and improve clinical outcomes in hospitalized COVID-19 patients, particularly those with severe disease or immunocompromised status.
Approved indications
- COVID-19 (severe or life-threatening disease)
- COVID-19 (hospitalized patients)
Common side effects
- Transfusion-related acute lung injury (TRALI)
- Allergic reactions
- Transfusion-associated circulatory overload (TACO)
- Fever
Key clinical trials
- Analysis of Coronavirus Disease 19 (COVID-19) Convalescent Plasma
- Efficacy of Reinforcing Standard Therapy in COVID-19 Patients With Repeated Transfusion of Convalescent Plasma (NA)
- Early High-Titre Convalescent Plasma in Clinically Vulnerable Individuals With Mild COVID-19 (PHASE3)
- Convalescent Plasma for Early Treatment of COVID-19 (PHASE2)
- Therapeutic Plasma Exchange Followed by Convalescent Plasma Transfusion in Severe and Critically Ill COVID-19 Patients (NA)
- Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia (PHASE3)
- Australasian COVID-19 Trial (ASCOT) ADAptive Platform Trial (PHASE3)
- Efficacy and Safety of Convalescent Plasma in Treating COVID-19 Hospitalized Patients (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- COVID19 convalescent plasma infusion CI brief — competitive landscape report
- COVID19 convalescent plasma infusion updates RSS · CI watch RSS
- Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno portfolio CI
Frequently asked questions about COVID19 convalescent plasma infusion
What is COVID19 convalescent plasma infusion?
How does COVID19 convalescent plasma infusion work?
What is COVID19 convalescent plasma infusion used for?
Who makes COVID19 convalescent plasma infusion?
What drug class is COVID19 convalescent plasma infusion in?
What development phase is COVID19 convalescent plasma infusion in?
What are the side effects of COVID19 convalescent plasma infusion?
Related
- Drug class: All Passive immunotherapy / Convalescent plasma drugs
- Manufacturer: Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno — full pipeline
- Therapeutic area: All drugs in Immunology / Infectious Disease
- Indication: Drugs for COVID-19 (severe or life-threatening disease)
- Indication: Drugs for COVID-19 (hospitalized patients)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing